"REFILL" | Dr. Brian Miller on FDA Regulatory Reform and the Valley of Death in Medical Innovation (Originally Aired: March 21, 2025)

In this "Refill" episode, Joe Grogan sits down with Dr. Brian Miller to discuss the "Valley of Death" - the gap between FDA approval and CMS coverage - and how regulatory reform can accelerate medical innovation. Miller explains how FDA product review can be made more efficient through automation and algorithmic analysis of routine tasks, allowing highly trained reviewers to focus on clinical interpretation rather than data processing. The conversation covers clinical trial reform, device review modernization, third-party review programs, and CMS coverage decision processes. Miller argues that these are operational challenges that can be fixed with executive leadership, and that transforming FDA and CMS procedures is critical to bringing new medicines and devices to patients faster.Key Timestamps1:23&nbsp; Brian Miller background and AEI role2:47&nbsp; The Valley of Death - gap between FDA approval and CMS coverage5:06&nbsp; Making FDA and CMS review processes more synergistic7:43&nbsp; Example of hypertension drug review and routine tasks8:26&nbsp; Data overload in FDA review process10:40&nbsp; Supplemental applications and unnecessary information12:01&nbsp; FDA reviewer burnout and middle management proliferation15:30&nbsp; Automating routine tasks at FDA17:33&nbsp; Clinical trial reform discussion and regulatory risk20:03&nbsp; Practical approach for new FDA commissioner and DOGE21:22&nbsp; Operational changes needed at FDA22:48&nbsp; Tobacco regulation at FDA and resource allocation25:10&nbsp; Device world getting short shrift in FDA priorities27:33&nbsp; Third-party 510k review program and third-party organizations29:09&nbsp; COVID diagnostic tests and pandemic review process30:51&nbsp; Reforming CDRH through third-party reviews31:36&nbsp; 70-year comparison of heart attack treatment advances32:46&nbsp; CMS coverage decisions and Coverage with Evidence Development36:02<s